JMIR Publications

ABSTRACT

Background:

Background:

Continuous hemodynamic monitoring is the standard of care for patients intraoperatively, but vital signs monitoring is performed only periodically on post-surgical wards, and patients are routinely discharged home with no surveillance. Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration.

Objective:

Objective:

Our aim was to validate the accuracy of the Cloud DX Vitaliti™ Continuous Vital Signs Monitor (CVSM) continuous non-invasive blood pressure measurements in post-surgical patients. Usability of the Vitaliti™ CVSM was also examined.

Methods:

Methods:

Included patients were recovering from surgery in a cardiac intensive care unit. Validation procedures were according to AAMI - ISO 81060-2 2013 standards for Wearable, Cuffless Blood Pressure Measuring Devices. In static (seated in bed) and supine positons, three 30-second cNIBP measurements were taken for each patient with the Vitaliti™ CVSM and an invasive arterial catheter. The errors of these determinations were calculated. Participants were interviewed about device acceptability

Results:

Results:

Data for 21 patients were included in the validation analysis. The overall mean and SD of the errors of determination for the static position were -0.784 mmHg (SD 4.594) for systolic blood pressure and 0.477 mmHg (SD 1.668) for diastolic blood pressure. Errors of determination were slightly higher for the supine position at 3.533 mmHg (SD 6.335) for systolic blood pressure and 3.050 mmHg (SD 3.619) for diastolic blood pressure. The majority rated the Vitaliti™ CVSM as comfortable.

Conclusions:

Conclusion: The Vitaliti™ CVSM was compliant with AAMI-ISO 81060-2:2013 standards and well-received by patients. Clinical Trial: Trial Registration: ClinicalTrials.gov (NCT03493867)